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临床试验/CTRI/2019/09/021388
CTRI/2019/09/021388尚未招募2/3 期

Comparison of surgical site infection (SSI) between negative pressure wound therapy assisted delayed primary closure and conventional delayed primary closure in grossly contaminated emergency abdominal surgeries: A randomised controlled trial

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
86
试验地点
1
主要终点
Rate of Surgical site infection

研究概览

简要总结

SSI has a great burden over the patients and also over the healthcare system in terms of cost and hospital length of stay. Negative pressure wound therapy has a great impact on wound healing and also to decrease the SSI rates. This has been shown in previous studies in closed abdominal wounds. Previous studies have been done to assess the role of negative pressure wound dressing in decreasing the SSI in closed abdominal wounds and other type of wounds. But none of the study have been done to see the efficacy of negative pressure wound dressing in delayed primary closure wound in terms of decreasing the rate of SSI.

Our study includes all patients undergoing grossly contaminated emergency abdominal surgeries through mid-line incision. Post operative periods, skin will be will be closed with delayed primary intention in all patients and will be closed on post operative day 5. In one group, conventional wound dressing will be done. and in another group, negative pressure assisted wound dressing will be done. Primary outcome is to assess the rate of SSI within 30 days of surgery and secondary outcomes to assess the rates of other surgical site complications i.e. hematoma, seroma, sheath dehiscence and burst abdomen and the hospital length of stay.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •All abdominal emergency cases with features of peritonitis undergoing laparotomy with open mid-line incision.
  • •All class-IV (dirty) wounds.
  • •Laparoscopy surgeries converted to open surgeries.

排除标准

  • •Laparoscopy surgeries.
  • •Elective procedures.
  • •Allergic to adhesive materials.

结局指标

主要结局

Rate of Surgical site infection

时间窗: 30 days

次要结局

  • Rates of other surgical site complications i.e. hematoma, seroma, sheath dehiscence and burst abdomen.(Hospital length of stay.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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